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Assessment of macula function recovery using MAIA microperimetry after Epiretinal membrane peeling surgery.

Assessment of macula function recovery using MAIA microperimetry after Epiretinal membrane peeling surgery.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000997459
Enrollment
100
Registered
2016-07-28
Start date
2016-08-01
Completion date
2017-04-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study Design: This is a prospective, non-randomised observational study which will follow post operative progress of patients who have been diagnosed with symptomatic Epiretinal membrane and will undergo epiretinal membrane peeling surgery over a 12 month period. Population: 100 eligible subjects will be recruited from Sydney Retina Clinic & Day Surgery, Australia. Study Duration: The study will be conducted over 18 months (6-month recruitment period and 12 month treatment and follow up period). Primary Objective: To evaluate the rate and amount of macular functional recovery using visual acuity, MAIA microperimetry and visual functioning questionnaires and to correlate this with anatomical change on SD OCT over 12 months. The aim will also be to determine prognostic indicators of poor visual outcome post surgery. 3. The change of retinal function measured by Macular Integrity Assessment (MAIA) microperimetry (including central threshold, average threshold, fixation stability and macular integrity) at months 1, 3, 6 and 12 months. Secondary Objectives: 1. Mean change in visual acuity at months 1, 3, 6 and 12 compared to the baseline using snellens chart at 6m 2. Mean change in central macular thickness measured by SD-OCT at months 1, 3, 6 and 12 compared to the baseline

Interventions

Patients who are diagnosed with Epiretinal Membrane who will undergo microperimetric testing pre and Pars plana vitrectomy membrane peeling surgery. Exposure being studied in this study: Fundus- driven microperimetry Microperimetry is a technology that allows concurrent analysis of structural and functional aspects of the retina. It combines fundus imaging, retinal sensitivity mapping and fixation analysis in one exam and has been used over a decade as a powerful tool to detect, describe and

Patients who are diagnosed with Epiretinal Membrane who will undergo microperimetric testing pre and Pars plana vitrectomy membrane peeling surgery. Exposure being studied in this study: Fundus- driven microperimetry Microperimetry is a technology that allows concurrent analysis of structural and functional aspects of the retina. It combines fundus imaging, retinal sensitivity mapping and fixation analysis in one exam and has been used over a decade as a powerful tool to detect, describe and follow-up pathologies affecting the macular area. Its great advantage is the ability to track patients’ fixation activity while measuring visual field, hence eliminating errors caused by fixation losses. It is a non-invasive test and can be easily performed by most patients including those with low vision. It works by presenting light stimuli it a unit (one eye is occluded at a time) and the patient is given a button which they press when the stimulus is detected. The microperimetry test will be conducted on the patients by a member of the research team (Ophthalmic registrar, clinical research officer) using a standardised protocol at the clinic. The test takes approximately 5 mins per eye. We will try to ensure the same operator will conduct subsequent follow up test for a particular patient. The baseline test will be performed within 4 weeks prior to the patient undergoing surgery and then at 1,3,6 and 12 months post surgery. The data will be collected at these time points.

Sponsors

Sydney Retina Clinic and Day Surgery
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Ability to provide informed consent and complete study assessments 2. Age 18 years or older 3. Best corrected baseline visual acuity between 6/60 to 6/9 in the study eye with a documented drop in BCVA 4. Diagnosed with Epiretinal membrane and consented to undergo ERM peeling surgery 5. Persistent metamorphopsia or micropsia for a period of at least 6 months

Exclusion criteria

1. Pregnancy or lactation 2. Intraocular surgery in the study eye within 2 months of baseline 3. Macular laser within 2 months or previous laser scar would prevent the improvement of macular function 4. Prior vitrectomy in the study eye 5. Current vitreous haemorrhage in the study eye 6. Active proliferative diabetic retinopathy in study eye 7. Active uveitis in study eye 8. Uncontrolled glaucoma in the study eye defined as intraocular pressure greater than 30mmHg on maximal medical therapy 9. Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion) 10. An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy) 11. Uncontrolled diabetes mellitus, as defined by hemoglobin A1C (HbA1c) > 12% 12. Dense lens media opacity 13. History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment 14. Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026